Esophageal Balloon Guided Weaning of the Morbidly Obese Patient

Not Applicable

Terminated

• Conditions: Morbid Obesity
• Interventions: Other: Cstat; Device: Esophageal Balloon

• Registration Number: NCT02323009
• Lead Sponsor: East Carolina University

Brief Summary

This is a study to evaluate whether PEEP adjusted by use of an esophageal balloon to overcome negative transpulmonary pressure; or adjusted by use of "CStat" to achieve the best effective static compliance will have any effect on outcomes with respect to ventilator weaning in tracheotomized morbidly obese patients (BMI \>=40) with at least one failed prior weaning attempt.

Detailed Description

Tracheotomized morbidly obese patients (BMI \>= 40) who had failed an initial attempt at ventilator weaning (defined in the investigators study as ventilator dependent) were randomly assigned to one of two methods for setting Positive End Expiratory Pressure (PEEP).

Patients randomized to the esophageal balloon arm (ESO group) had their PEEP adjusted to overcome negative transpulmonary pressure and maintain a positive transpulmonary pressure (Ptp) of 0 to 10 cm H20 - targeting as close to zero as possible.

Patients randomized to the static effective compliance arm (CStat group) had their PEEP adjusted to achieve the best static effective compliance as automatically calculated and displayed on the graphic interphase of the hamilton G5 or Galileo ventilator. For this group, the PEEP was adjusted in increments of 3 cm H20 until there was a less than 5% observed improvement in the static effective compliance. the PEEP with the best Cstat was chosen.

At the end of the intervention period, this intervention cohort (termed "PEEP intervention cohort") will be compared to a group of historical controls to compare the efficiency of a PEEP-based weaning protocol to traditional weaning methods.

The investigators hypothesized that PEEP levels titrated by use of an esophageal balloon to maintain a positive transpulmonary pressure between 0 to 10 cm H20, would lead to improved outcomes with respect to ventilator weaning in this subset of patients.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2014-12
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-17
• Last Update Submitted: 2014-12-17
• Study First Posted: 2014-12-23
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Morbidly obese patients with BMI of 40 or greater
• Ventilator dependent patients (defined as at least one prior failure at weaning)
• Tracheotomized
• No active underlying lung disease that would preclude ventilator weaning
• Stable hemodynamics
• Patient/ family able to give consent
• No naso-facial abnormalities that would interfere with placement of an esophageal balloon
• Fio2 <= 60%
• Patient able to tolerate Pressure Support ventilation

Exclusion Criteria

• Lack of consent
• Patient deemed not weanable from mechanical ventilation as per the clinical judgement of the pulmonary physician
• Significant lung, heart or neuromuscular disease that would interfere with or preclude ventilator weaning, including an active ongoing lung infection.
• Contraindications to placement of an esophageal pressure monitoring device - such as ulcerations, tumors, diverticulitis, uncontrolled bleeding varices, sinusitis, epistaxis or recent nasopharyngeal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cstat Arm	Cstat	Patients in this arm had their PEEP adjusted to achieve the best static effective compliance (CStat).
Esophageal balloon Arm	Esophageal Balloon	Patients in this arm were randomly assigned to have their PEEP adjusted to maintain a positive transpulmonary pressure (0 to 10 cm H20).

Primary Outcome Measures

Name	Time	Method
Number of patients weaned by day 30	30-days	A patient was considered successfully weaned and "ventilator independent" if they were spontaneously breathing without ventilator support for at least 24 hours, and remained off the ventilator by day 30. If ventilator support was subsequently required, the patient was returned to their original group and considered not weaned. The patients were considered to be weaned or not, after a period of thirty days.

Secondary Outcome Measures

Name	Time	Method
Time to wean	30-days	The time to wean/ time to achieve ventilator independence was measured from the date of randomization to the date of final successful liberation from mechanical ventilation. If patient had an unsuccessful initial wean, he was not considered weaned. Only patients who were considered weaned by day 30 accrued "time to ventilator independence."

Trial Locations

Locations (1)

Vidant Medical Center; 🇺🇸 Greenville, North Carolina, United States